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NCT00693121 · ClinicalTrials.gov registry record · Phase 4
Amantadine for Treatment of Symptoms of the Post-traumatic Confusional State
A Phase 4 study, sponsored by Methodist Rehabilitation Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 79
- Enrollment target
NCT00693121: Completed Phase 4 study, sponsored by Methodist Rehabilitation Center.
NCT00693121 is a Phase 4 study that has completed, run by Methodist Rehabilitation Center. The registered enrollment target is 79 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00693121, a Phase 4 study, has completed, sponsored by Methodist Rehabilitation Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 79 participants
- Enrollment target
Study Summary
Patients with traumatic brain injury often experience a period of acute confusion that may include agitation as they recover from their injuries. While this confusion generally resolves with time, patients may pose increased risk of injury to themselves or others during this period. Their behavior may also increase stress for family members and interfere with their ability to benefit from rehabilitation therapies. A number of different medications have been used to treat confusion to decrease agitation, decrease risk of injury, and improve participation in rehabilitation therapies. To this point, there has not been a research or scientific basis for knowing which medication is the best for a specific patient. The overall goal of this study is to conduct a scientific investigation to help determine which medication works best to treat confusion. Study hypothesis: Amantadine will reduce the severity and number of symptoms of acute confusion after traumatic brain injury.
Interventions
- DRUG Placebo capsule
- DRUG Amantadine hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 79 participants |
| Start Date | 2003-04 |
| Est. Completion | 2019-03 |
| Phase | Phase 4 |
What the finished NCT00693121 record still lists
NCT00693121 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 79 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo capsule is the first listed.
NCT00693121 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00693121 about?
NCT00693121 is a clinical study titled "Amantadine for Treatment of Symptoms of the Post-traumatic Confusional State". Patients with traumatic brain injury often experience a period of acute confusion that may include agitation as they recover from their injuries. While this confusion generally resolves with time, patients may pose increased risk of injury to themselves or others during this period. Their behavior m...
What is the current status of trial NCT00693121?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 79 participants. The study started on 2003-04. Estimated completion is 2019-03.
What interventions are being tested in trial NCT00693121?
The interventions under investigation include: Placebo capsule (DRUG), Amantadine hydrochloride (DRUG).
Who is sponsoring clinical trial NCT00693121?
This trial is sponsored by Methodist Rehabilitation Center, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00693121's enrollment target sits among peer trials
79 980th of 2000 higher than 1,019 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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